Status:
WITHDRAWN
The Effects of SlumberCurve™ Following Rotator Cuff Surgery: a Randomized Control Trial
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
Eight28, LLC
Conditions:
Rotator Cuff Tears
Surgery
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
The purpose of this study is to investigate the effects of a novel sleep aid known as SlumberCurve™, which serves as an adjustable form of a wedge pillow, on sleep quality and pain management followin...
Detailed Description
Poor sleep quality is prevalent among patients undergoing rotator cuff repair surgery, and negatively affects the potential for proper healing. Without adequate sleep, the production of anabolic stero...
Eligibility Criteria
Inclusion
- • Any male or nonpregnant female aged 18 years or older with a full-thickness rotator cuff tear undergoing rotator cuff repair surgery
Exclusion
- Patients who receive workers' compensation benefits
- Patients with irreparable tears
- Patients undergoing revision surgery
- Patients with concomitant severe glenohumeral arthritis or concurrent adhesive capsulitis
- Sleep apnea disorder or other diagnosed sleep disorder
- Neuropsychiatric disease
- Use of sleep medication
- Prior shoulder surgery
- Rotator cuff arthropathy with pseudo paralysis
- Acute fractures involving the proximal humerus or shoulder girdle
Key Trial Info
Start Date :
June 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04774965
Start Date
June 30 2023
End Date
June 24 2024
Last Update
March 19 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.